Panel urges revised warning on facial filler risks

WASHINGTON 
Cosmetic surgery patients who think facial fillers are a magical antidote to aging must be better informed of possible risks, government health advisers said Tuesday.

A panel of independent advisers urged the Food and Drug Administration to revise information for consumers and doctors – called the product label – to include the risk of long lasting reactions such as bumps under the skin, blotches and scars.

"This is almost a no-brainer," said panel member Dr. Michael Bigby, a Harvard Medical School dermatologist. "The current label is not adequate." The panel of doctors other experts unanimously agreed on the need for more safety studies.

The gel-like fillers have become immensely popular with baby boomers. Injected into the face, they smooth away wrinkles. Most patients get a couple of touchups a year, at a cost that can easily exceed $1,000 each.

Manufacturers and plastic surgeons say fillers have an excellent safety record. But Tuesday's FDA hearing raised questions about unapproved uses, untrained technicians giving injections, and a lack of long-term safety data. It was a first step as the FDA considers whether to regulate fillers more closely.

Plastic surgeons pledged to help find a new consensus on how to track safety, improve training and provide clearer information to consumers. "We feel it's time for medicine to step up and take the lead," said Dr. Richard D'Amico of New Jersey, representing the American Society of Plastic Surgeons.

Women, and some men, are drawn to fillers by the promise of youthful good looks for less cost and trouble than a face lift. It's also a boost for deflated middle-age egos.

Different from Botox, which is derived from a toxin that acts on facial muscles, wrinkle fillers are like the biological equivalent of a bit of spackle, except they're injected. They include such products as Juvederm, made by Allergan, Inc., and Restylane, from Medicis Aesthetics Holdings.

FDA officials are concerned that fillers are being used for purposes they were never tested nor approved for, not just erasing wrinkles.These include plumping the lips, cheeks and breasts.

"The trouble is that once this material is in the hands of physicians, there's really not much control over how it's used and where it's placed," said Dr. Scott Spear, a Washington plastic surgeon. "That creates the potential for a certain amount of mischief.

"But the good news is that, by and large, these are very safe materials," Spear added. "They have a very healthy risk profile."

The FDA also has questions how darker-skinned patients fare with the beauty treatments. More black, Latino and Asian patients are trying plastic surgery, and some information suggests they may be susceptible to unsightly blotches and other complications.

Plastic surgeons performed some 1.5 million cosmetic surgery procedures with fillers last year alone.

The FDA presented data on 823 patients who suffered serious reactions after treatment with fillers between 2003 and this September. Nearly all were women, and the most common age group was 50- to 60-year-olds.

Although no deaths were reported, the complications were troublesome enough that 638 of the patients required follow-up medical treatment.

"Patients don't want to get rid of wrinkles and end up with large bumps on the face instead," said consumer activist Diana Zuckerman, president of the National Research Center for Women & Families.

Most cases reported to the FDA involved complications that could be foreseen, such as swelling and redness. But there were also "serious and unexpected" reactions, including facial, lip and eye paralysis, disfigurement, vision problems and some severe allergic reactions.

Nineteen patients went to the emergency room with life-threatening allergic reactions. Twelve developed infections that required hospitalization.

Some problems reported to the FDA may be due to unapproved or "off-label" use of fillers. For example, the FDA does not recommend them for plumping the lips, but some doctors see no problem with that.

Another challenge is the sheer variety of fillers. Most are eventually absorbed into the body, but one type contains tiny, round, smooth plastic particles that the body does not absorb. Some are made from natural substances and others are not. That means they may react differently in the body.

"Some of these products don't have a lot of adverse events and some do," said Zuckerman. "How are we going to help patients make decisions without more information?"